Application 073607

Type: ANDA
Sponsor: MAYNE PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	TABLET;ORAL	25MG;250MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A073607-001	CARBIDOPA AND LEVODOPA	CARBIDOPA; LEVODOPA	25MG;250MG	TABLET / ORAL	AB		1992-08-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A073607-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A073607-001	CARBIDOPA AND LEVODOPA	25MG;250MG	TABLET / ORAL	AB	1992-08-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A073607-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A073607-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A073607-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A073607-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A073607-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A073607-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A073607-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A073607-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A073607-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A073607-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A073607-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A073607-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A073607-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A073607-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A073607-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A073607-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A073607-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A073607-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A073607-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A073607-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A073607-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A073607-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A073607-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A073607-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A073607-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A073607-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A073607-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A073607-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A073607-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A073607-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A073607-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A073607-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A073607-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A073607-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A073607-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A073607-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A073607-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A073607-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A073607-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A073607-001	AB	1	`cb3db0bc1861…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Major Pharmaceuticals	3f6d393e-ac84-4a3c-a837-199d1ec71fd2	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073607 application number: ANDA073607
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Dr. Reddy's Laboratories Inc	87ab55c9-203d-d595-3e3e-0e38f2f6d9c4	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073607 application number: ANDA073607
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	Cardinal Health 107, LLC	19d853e2-b8bd-490e-b8d2-b38bec68a139	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073607 application number: ANDA073607
Carbidopa and Levodopa	CARBIDOPA AND LEVODOPA	NCS HealthCare of KY, LLC dba Vangard Labs	45909de3-0852-4e61-8a9e-23f8fcc2463a	2024-12-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 073607 application number: ANDA073607

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8011	Carbidopa and Levodopa	Carbidopa and Levodopa	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8275	Carbidopa and Levodopa	Carbidopa and Levodopa	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8275	Carbidopa and Levodopa	Carbidopa and Levodopa	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8275	Carbidopa and Levodopa	Carbidopa and Levodopa	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
51407-168	Carbidopa and Levodopa	Carbidopa and Levodopa	Golden State Medical Supply Inc.	ANDA	Current
51407-168	Carbidopa and Levodopa	Carbidopa and Levodopa	Golden State Medical Supply	ANDA	Current
51407-168	Carbidopa and Levodopa	Carbidopa and Levodopa	Golden State Medical Supply	ANDA	Current
51862-858	Carbidopa and Levodopa	Carbidopa and Levodopa	Mayne Pharma Inc.	ANDA	Current
51862-858	Carbidopa and Levodopa	Carbidopa and Levodopa	Mayne Pharma Inc.	ANDA	Current
63739-048	Carbidopa and Levodopa	Carbidopa and Levodopa	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-048	Carbidopa and Levodopa	Carbidopa and Levodopa	McKesson Corporation	ANDA	Current